The With Or Without Olecranon K-wires Trial

NCT05657899 | Recruiting DMC

• 1 other identifier: DSF-220510-2038
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

Fractures of the elbow tip (olecranon) that leave the elbow joint stable but where the fracture ends are separated (Mayo type 2a and 2b) can be treated with pins and a metal wire (tension band wiring, TBW) or metal wiring alone (cerclage fixation, CF ). Previous studies have reported high re-operation and complication rates following TBW. The current study's hypothesis, based on two retrospective studies, is that CF of these fractures yield lower re-operation rates compared with TBW. The investigators also hypothesize that the overall complication rate will be lower following CF. The aim is to investigate this hypothesis in a randomized controlled trial. Patients that are 18 years or older with Mayo type 2a and 2b olecranon fractures at Skåne University hospital will be invited to the study. Participation is voluntary. Patients who accept participation will be randomly assigned to surgery by either TBW or cerclage fixation. Two hundred participants will be followed by physiotherapists for 36 months post-surgery assessing re-operations, complications, patient reported outcome, and elbow function.

Conditions

Olecranon Fracture

Keywords

Tension Band Wiring; Cerclage; Surgery; Elbow injuries; Forearm injuries; Ulna fractures; Patient reported outcome measures

Outcome Measures

Primary Outcomes (4)

• Re-operation rate 1.5 months.

  Total re-operation rate of the operated elbow regardless of cause.

  Recorded at 1.5 months after intervention.

• Re-operation rate 3 months.

  Total re-operation rate of the operated elbow regardless of cause.

  Recorded at 3 months after intervention.

• Re-operation rate 12 months.

  Total re-operation rate of the operated elbow regardless of cause.

  Recorded at 12 months after intervention.

• Re-operation rate 36 months.

  Total re-operation rate of the operated elbow regardless of cause.

  Recorded at 36 months after intervention.

Secondary Outcomes (21)

• Complication rate 1.5 months.

  Recorded at 1.5 months after intervention.

• Complication rate 3 months.

  Recorded at 3 months after intervention.

• Complication rate 12 months.

  Recorded at 12 months after intervention.

• Complication rate 36 months.

  Recorded at 36 months after intervention.

• Complication severity 1.5 months.

  Recorded at 1.5 months after intervention.

Other Outcomes (22)

• Grip strength 0.5 months.

  Recorded at 0.5 months after intervention.

• Grip strength 1.5 months.

  Recorded at 1.5 months after intervention.

• Grip strength 3 months.

  Recorded at 3 months after intervention.

Study Arms (2)

Cerclage

ACTIVE COMPARATOR

Intervention by cerclage fixation.

Procedure: Cerclage fixation

Tension Band Wiring

ACTIVE COMPARATOR

Intervention by tension band wiring

Procedure: Tension band wiring

Interventions

Cerclage fixation PROCEDURE

The intervention is by surgical open reduction and internal fixation of the fracture using two 1.0mm cerclage.

Cerclage

Tension band wiring PROCEDURE

The intervention is by surgical open reduction and internal fixation of the fracture using a 1.0mm cerclage and two 1.6 mm k-wires as described in AO-guidelines.

Tension Band Wiring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sustained Olecranon type fracture of Mayo 2a or 2b
• Seeking healthcare in at the Skåne University Hospital in Lund and Malmö, Sweden.

You may not qualify if:

• Subjects unable to participate in follow up (for example subjects with active substance abuse, dementia, inability to communicate or understand the questionnaires or subjects living in other administrative healthcare regions).
• Subjects unable to give informed written consent.
• Subject where non operative treatment is indicated due to frailty or severe ongoing disease.
• Fracture not operated within 14 days from the date the fracture was sustained.
• Subjects with severe open fractures of Gustilo-Anderson class III
• Subject with pathological fractures from metastatic disease.
• Subject with simultaneous or previous severe injury to the same arm are excluded for patient reported outcome measures but included for all other outcomes.
• Subjects with previously severe injuries to the same arm will be excludes for PROM analyses but included for reoperation and complication analyses.
• Subjects operated by an orthopedic trauma surgeons that did not attended our education on the study and the interventions, unless surgery is supervised by an orthopedic surgeon that has attended the education the subject will not be excluded.

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator

Study Sites (2)

Dept. of Orthopaedics

Lund, Skåne County, 22242, Sweden

RECRUITING

Dept. of Orthopaedics

Malmo, Skåne County, 20502, Sweden

RECRUITING

Related Publications (6)

• Wenger D, Cornefjord G, Rogmark C. Cerclage fixation without K-wires is associated with fewer complications and reoperations compared with tension band wiring in stable displaced olecranon fractures in elderly patients. Arch Orthop Trauma Surg. 2022 Oct;142(10):2669-2676. doi: 10.1007/s00402-021-04027-3. Epub 2021 Jul 8.

  PMID: 34236459 BACKGROUND

• Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.

  PMID: 8773720 BACKGROUND

• Gries MW. Safety professional's role as health educator expanding. Occup Health Saf. 1984 Feb:42-3. No abstract available.

  PMID: 6709254 BACKGROUND

• Williams N. The Short Musculoskeletal Function Assessment (SMFA) questionnaire. Occup Med (Lond). 2016 Dec;66(9):757. doi: 10.1093/occmed/kqw140. No abstract available.

  PMID: 27994082 BACKGROUND

• Ponzer S, Skoog A, Bergstrom G. The Short Musculoskeletal Function Assessment Questionnaire (SMFA): cross-cultural adaptation, validity, reliability and responsiveness of the Swedish SMFA (SMFA-Swe). Acta Orthop Scand. 2003 Dec;74(6):756-63. doi: 10.1080/00016470310018324.

  PMID: 14763711 BACKGROUND

• Cornefjord G, Kostogiannis I, Rogmark C, Jerrhag D, Wenger D. The With Or Without Olecranon K-wire (WOW OK) Trial of tension band wire fixation versus cerclage fixation without K-wires in displaced stable olecranon fractures: study protocol for a randomized controlled trial. Trials. 2023 Aug 29;24(1):559. doi: 10.1186/s13063-023-07566-9.

  PMID: 37641082 DERIVED

MeSH Terms

Conditions

Olecranon Fracture; Elbow Injuries; Forearm Injuries; Ulna Fractures

Condition Hierarchy (Ancestors)

Elbow Fractures; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Daniel Wenger, MD, PhD

  Department of Orthopedics, Skåne University Hospital and Lund University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Wenger, MD, PhD

CONTACT

+46 73-815 15 50; daniel.wenger@med.lu.se

Gustav Cornefjord, MD

CONTACT

+46 70-561 45 35; gustav.cornefjord@skane.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor of all outcome measures except assessment of a postoperative radiograph will be masked. When the radiograph is viewed the operative method will be apparent, but this assessor is not the same as for the other outcome measures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: December 20, 2022
• Study Start: January 1, 2023
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)